JPRN-jRCT2080224589
Recruiting
Phase 1
An open-label Phase 1 study of E7386 in subjects with advanced solid tumors including colorectal cancer
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Solid tumor, Colorectal cancer, Gastrointestinal tumor, Small bowel carcinoma, Desmoid tumo, Adrenocortical carcinoma, Solid pseudopapillary neoplasm of pancreas
- Sponsor
- Eisai Co., Ltd.
- Enrollment
- 70
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Subjects with a histological and/or cytological diagnosis of solid tumor must have any of the following tumor types:
- •Dose Escalation part: Subjects with advanced, unresectable, or recurrent solid tumor including CRC for which no alternative standard therapy or no effective therapy exists
- •Expansion Part 1:
- •Subjects with advanced, unresectable, or recurrent CRC in third\- or later\-line, Or subjects with other gastrointestinal tumors such as small bowel carcinoma and gastrointestinal neuroendocrine tumors after at least 1 prior systemic chemotherapy regimen upon discussion and agreement with the sponsor.
- •Expansion Part 2:
- •Subjects with advanced, unresectable, or recurrent solid tumors expected to be highly dependent on Wnt/beta\-catenin signaling pathway as specified below, who have no standard therapy. Disease progression must be confirmed within the past 12 months.
- •\-Desmoid tumor
- •\-Solid pseudopapillary neoplasm (SPN) of pancreas
- •As for subjects with solid tumors below, gene mutations should be confirmed with Sponsor\-approved assays.
- •\-Small bowel carcinoma with mutation of CTNNB1 or APC
Exclusion Criteria
- •1\.Major surgery within 21 days prior to starting study drug
- •2\.Known to be human immunodeficiency virus (HIV) positive
- •3\.Active infection requiring systemic treatment
- •4\.Diagnosed with meningeal carcinomatosis
- •5\.Subjects with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study. Any signs (e.g., radiologic) or symptoms of brain metastases must be stable for at least 4 weeks before starting study treatment.
- •6\.Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen.
- •7\.Inability to take oral medication, or malabsorption syndrome or any other uncontrolled gastrointestinal condition (eg, nausea, diarrhea, or vomiting) that might impair the bioavailability of E7386\.
- •8\.Any of the bone disease/conditions as follows;
- •\- Osteoporosis with T\-score of \< \-3\.0 at the left or right total hip, left or right femoral neck or lumbar spine (L1\-L4\) as determined by dual energy x\-ray absorptiometry (DXA) scan. Subjects with T\-score \<\-2\.5 to \-3\.0 and no prior medical therapy for osteoporosis can only be included provided that treatment with a bisphosphonate (eg, zoledronic acid) or denosumab has been started at least 14 days prior to the first dose of study drug.
- •\- Metabolic bone disease, such as hyperparathyroidism, Paget's disease or osteomalacia
Outcomes
Primary Outcomes
Not specified
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